Iso Certification Company in Pune

Iso 13485 2016 certification in thane

 

The Iso 9001 2015 certification in delhi & Quality management certification standard is one of the best known international standards; it is implemented by countless companies and other organizations in over 150 countries. It is a customer focused standard. It is about effectively controlling key processes of an organization in order to continually improve and achieve customer's satisfaction. ISO 9001 addresses "quality management". This means what the organization does to fulfill:

- their customers' quality requirements, plus
- any applicable regulatory requirements,

While aiming to

- enhance customer satisfaction, and
- Achieve continual improvement of its performance.

EC International certifications clients have an enviable record for customer satisfaction with its certification services.Iso 9001 2015 certification in delhi & Quality management certification


  • Years of Experience: 15+ Years
  • Global Presence: 50+ Countries.
  • No. of Consultants: 300+ People
  • Projects Completed: 4500+ Certifications
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Who we are?

EC International Certifications is a professional certification and consulting firm offering CE Mark Certification services in thane. We provide 100% success guarantee for CE Mark Certification in thane. We are an Approved Service Provider with extensive knowledge and experience in all International Quality Assurance Standards. We will be happy to assist your company in the CE Mark Certification process.

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Iso 13485 2016 certification in thane

Iso 13485 2016 certification in thane is an internationally recognized quality standard which states the requirements of the Quality Management System (QMS) for the design and manufacture of Medical device directive in thane. While it remains a stand-alone document, ISO 13485:2016 is based on ISO 9001:2008 with some additional clauses as well as the removal of some requirements. ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective of ISO 13485:2016 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001. All requirements of Iso 13485 2016 certification in thane & medical device directive certification in thane & Management system certification are specific to organizations providing medical devices, regardless of the type or size of the organization.

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